WO2018165225A1 - Systems, methods and devices for prosthetic heart valve with single valve leaflet - Google Patents
Systems, methods and devices for prosthetic heart valve with single valve leaflet Download PDFInfo
- Publication number
- WO2018165225A1 WO2018165225A1 PCT/US2018/021244 US2018021244W WO2018165225A1 WO 2018165225 A1 WO2018165225 A1 WO 2018165225A1 US 2018021244 W US2018021244 W US 2018021244W WO 2018165225 A1 WO2018165225 A1 WO 2018165225A1
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- WO
- WIPO (PCT)
- Prior art keywords
- valve
- leaflet
- valve support
- base side
- annulus
- Prior art date
Links
- GAFQJKHEQUJHBR-ZNOXQBFJSA-N BN[C@@H](C)C(CCC1)C1(CC)C(C)CC Chemical compound BN[C@@H](C)C(CCC1)C1(CC)C(C)CC GAFQJKHEQUJHBR-ZNOXQBFJSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0071—Three-dimensional shapes spherical
Definitions
- the invention relates to supplementing and/or replacing native heart valve leaflet function.
- the human heart comprises four chambers and four heart valves that assist in the forward (antegrade) flow of blood through the heart.
- the chambers include the left atrium, left ventricle, right atrium and left ventricle.
- the four heart valves include the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve.
- the mitral valve is located between the left atrium and left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve to prevent backflow into the left atrium.
- the tricuspid valve is located between the right atrium and the right ventricle, while the aortic valve and the pulmonary valve are semilunar valves located in arteries flowing blood away from the heart.
- the valves are all one-way valves, with leaflets that open to allow forward (antegrade) blood flow. The normally functioning valve leaflets close under the pressure exerted by reverse blood to prevent backflow (retrograde) of the blood into the chamber it just flowed out of.
- Native heart valves may be, or become, dysfunctional for a variety of reasons and/or conditions including but not limited to disease, trauma, congenital malformations, and aging. These types of conditions may cause the valve structure to either fail to properly open (stenotic failure) and/or fail to close properly (regurgitant).
- Mitral valve regurgitation is a specific problem resulting from a dysfunctional mitral valve. Mitral regurgitation results from the mitral valve allowing at least some retrograde blood flow back into the left atrium from the left ventricle. This backflow of blood places a burden on the left ventricle with a volume load that may lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling of the ventricular chamber size and shape, that vary considerably during the prolonged clinical course of mitral regurgitation.
- a similar problem may occur when the tricuspid valve weakens or begins to fail.
- the tricuspid valve separates the right atrium and right ventricle.
- Tricuspid regurgitation also known as tricuspid insufficiency, occurs when the tricuspid valve doesn't properly close, causing blood to flow back up into the right atrium when the right ventricle contracts.
- Various embodiments of the present invention discussed herein may apply to mitral valve and/or tricuspid valve regurgitation.
- Native heart valves generally, e.g., mitral valves, therefore, may require functional repair and/or assistance, including a partial or complete replacement. Such intervention may take several forms including open heart surgery or open heart implantation of a replacement heart valve. See e.g., U.S. Pat. No. 4,106,129 (Carpentier), for a procedure that is highly invasive, fraught with patient risks, and requiring not only an extended hospitalization but also a highly painful recovery period.
- This self-expanded form also presents problems when, as is often the case, the device is not properly positioned in the first positioning attempt and, therefore, must be recaptured and positionally adjusted.
- This recapturing process in the case of a fully, or even partially, expanded device requires re-collapsing the device to a point that allows the operator to retract the collapsed device back into a delivery sheath or catheter, adjust the inbound position for the device and then re-expand to the proper position by redeploying the positionally adjusted device distally out of the delivery sheath or catheter. Collapsing the already expanded device is difficult because the expanded stent or wire network is generally designed to achieve the expanded state which also resists contractive or collapsing forces.
- gaining access to the valve of interest is achieved percutaneously via one of at least the following known access and delivery routes: femoral access, venous access, trans-apical, trans-aortic, trans-septal, trans-atrial, retrograde from the aorta delivery techniques.
- replacement heart valves are intended for full replacement of the native heart valve. Therefore, these replacement heart valves physically engage the annular throat and/or valve leaflets, thereby eliminating all remaining functionality of the native valve and making the patient completely reliant on the replacement valve.
- native valve has either lost virtually complete functionality before the interventional implantation procedure, or the native valve continues to lose functionality after the implantation procedure.
- the preferred solution is delivery and implantation of a valve device that will function both as an adjunctive and/or supplementary functional valve as well as be fully capable of replacing the native function of a valve that has lost most or all of its functionality.
- inventive solutions described infra will apply generally to all types and forms of heart valve devices, unless otherwise specified.
- Known solutions for, e.g., the mitral valve replacement systems, devices and methods require 2-chamber solutions, i.e., there is involvement and engagement of the implanted replacement valve device in the left atrium and the left ventricle.
- these solutions include a radially expanding stent in the left atrium, with anchoring or tethering (disposed downward through the native annulus or annular throat) connected from the stent device down through the annular throat, with the sub-annular surface within the left ventricle, the left ventricular chordae tendineae and even into the left ventricle wall surface(s). See, e.g., the MitraClip ® marketed by the Abbott Group and currently the only US approved repair device.
- a catheter containing the MitraClip ® is inserted into the femoral vein.
- the device enters the heart through the inferior vena cava to the right atrium and delivered trans- septally.
- the MitraClip ® passes through the annulus into the left ventricle and sits below the leaflets, clipping the leaflets to decrease regurgitation.
- Such 2-chamber and native annular solutions are unnecessary bulky and therefore more difficult to deliver and to position/recapture/reposition from a strictly structural perspective. Further, the 2-chamber solutions present difficulties in terms of making the ventricular anchoring and/or tethering connections required to hold position. Moreover, these solutions interfere with the native valve functionality as described above because the device portions that are disposed within the left ventricle must be routed through the native annulus and/or annular throat and native mitral valve, thereby disrupting any remaining coaptation capability of the native leaflets. In addition, the 2-chamber solutions generally require an invasive anchoring of some of the native tissue, resulting in unnecessary trauma and potential complication.
- known prosthetic cardiac valves consist of two or three leaflets that are arranged to act as a one-way valve, permitting fluid flow therethrough in the antegrade direction while preventing retrograde flow.
- the mitral valve is located retrosternally at the fourth costal cartilage, consisting of an anterior and posterior leaflet, chordae tendinae, papillary muscles, ventricular wall and annulus connected to the atria.
- Each leaflet is supported by chordae tendinae that are attached to papillary muscles which become taut with each ventricular contraction preserving valvular competence.
- Both the anterior and posterior leaflets of the valve are attached via primary, secondary and tertiary chordae to both the antero-lateral and posterio-medial papillary muscles.
- a disruption in either papillary muscle in the setting of myocardial injury can result in dysfunction of either the anterior or posterior leaflet of the mitral valve.
- Other mechanisms may result in failure of one, or both of the mitral leaflets.
- the regurgitation may take the form of a non-central, eccentric jet of blood back into the left atrium.
- Other leaflet failures may comprise a more centralized regurgitation jet.
- Known prosthetic valve replacements generally comprise leaflets which are arranged to mimic the native valve structure, which may over time become susceptible to similar regurgitation outcomes.
- Figure 1 A illustrates a side view of one embodiment of the present invention.
- Figure I B illustrates a bottom cutaway view of one embodiment of the present invention.
- Figure 2 A illustrates a cutaway bottom view of one embodiment of the present invention.
- Figure 2B illustrates a cutaway bottom view of one embodiment of the present invention.
- Figure 2C illustrates a cutaway bottom view of one embodiment of the present invention.
- Figure 3 illustrates a side view of one embodiment of the present invention.
- Figure 4 illustrates a side view of one embodiment of the present invention.
- Figure 5 illustrates a side view of one embodiment of the present invention.
- Figure 6 illustrates a side view of one embodiment of the present invention.
- Figure 7 illustrates a side view of one embodiment of the present invention.
- Figure 8 illustrates a bottom perspective view of one embodiment of the present invention.
- Figure 9 illustrates a bottom view of one embodiment of the present invention.
- Figure 10 illustrates a side view of one embodiment of the present invention.
- Figures 1 A and 1 B provides an exemplary expanded prosthetic valve device 100 adapted for implantation within a heart chamber, e.g., the left atrium.
- An anchoring portion 102 is shown with a wire, e.g., a stent, construction that may be open, or at least partially open, when expanded within an exemplary left atrium.
- Anchoring portion 102 may be hollow and may provide a flow channel, shown in dashed lines at 103 in Fig 1A, therethrough for blood flowing into the open wire construction of the anchoring portion 102 from the left pulmonary veins L into the left atrium where the device 100 is expanded and positioned for implantation.
- a lower section of anchoring portion 102 that is the section of the anchoring portion 102 that is located below the incoming blood flow points at the left pulmonary veins L, may be covered by fabric and/or tissue, either on the luminal side, the abluminal side, or on both the luminal and abluminal sides of the anchoring portion 102 to help channel the incoming blood flow into the flow channel 103 and to prevent paravalvular leakage.
- the flow channel in Figs 1 A and IB terminates at a lower edge 104 of the anchoring portion with an exemplary prosthetic leaflet 106 hingedly attached thereto.
- the lower edge 104 may comprise a generally circular profile, though other shapes are within the scope of the present invention.
- the undeformed expanded profile of the anchoring portion 102 and, in some cases, of the lower edge 104 may differ from a deformed expanded profile of anchoring portion 102 and lower edge 104 when the device 100 expands against atrial walls and the upper surface of the annulus.
- the embodiment illustrated in Fig 1 B comprises a single support wire, though a thicker configuration, e.g., a sewing ring, may also be provided.
- lower edge 104 comprises a structure that allows a hinged or flexing connection with the single prosthetic leaflet 106.
- a single prosthetic leaflet 106 may comprise a perimeter 108 and a leaflet attachment zone 1 10 located along a portion of the perimeter 108.
- leaflet 106 may be connected with the lower edge 104 of the anchoring structure 102 or may be a separate structure that is attached or connected with the lower edge 104 of anchoring portion 102.
- Perimeter 108 in these leaflets 106 comprise a width, and in some cases a thickness, that may be formed of a material that differs from the material of the inner region 105 to facilitate attachment to the lower edge 104 of anchoring portion 102.
- leaflet 106 may comprise a single material throughout as in Fig. 2C, wherein the perimeter 108 (shown in dashed lines) may comprise the same material as the inner region 105, though perimeter 108 may comprise a reinforced, e.g., double layer or folded layer of material.
- the leaflet 106 may comprise a circular or a geometric, e.g., hexagonal, outer profile, see e.g. Figs 2A and 2B. These are simply exemplary shapes, all other shapes are within the scope of the present invention, so long as the leaflet 106 covers the opening defined by the lower edge 104 of the anchoring portion 102. Accordingly, lower edge 104 may be shaped with a variety of shapes, e.g., circular, semi-circular, when either expanded and deformed or expanded and undeformed. Any shape for lower edge 104 of the anchoring portion 102 is within the scope of the present invention, so long as the leaflet 106 is sized and shaped to cover the opening defined by lower edge 104.
- FIG. 2 illustrates a series of connecting points which may be sutures or some other equivalent connective structure and that covers part of the outer surface of an exemplary circular valve leaflet such that the valve leaflet may swing open and closed using the connecting points as a hinge point.
- Figure 3 illustrates an exemplary hexagonal valve leaflet with a series of connecting points within a leaflet attachment zone along one side of the hexagonal valve leaflet.
- the connecting points within the leaflet attachment zone 1 10 may comprise a structure that consists of one or more unbroken connectors, including but not limited to adhesive or gluing, continuous stitching, integrally forming the valve leaflet 106 with the anchoring structure 102, preferably with the lower edge 104 thereof, and/or clamping the valve along the leaflet attachment zone 110 to the anchoring structure, again preferably with the lower edge 104 thereof.
- the prosthetic valve leaflet 106 thus acts like a hinged door in that it may rotate or swing between a closed position and an open position relative to the lower edge 104 of anchoring portion 102 with a portion of the leaflet 106 secured to a portion of the lower edge 104 of the anchoring portion 102 along the leaflet attachment zone 110 by, e.g., a plurality of sutures or the equivalent.
- the closed position results in a temporary engagement and sealing of an outer portion of the upper surface of the valve leaflet against the bottom surface of the lower edge 104 of the structure 102, the prosthetic valve leaflet 106 being of a size and shape to cover the opening defined by lower edge 104 of anchoring portion 102, thereby preventing retrograde blood flow therethrough.
- the open position disengages the upper surface of the valve leaflet 106 from the bottom surface of the lower edge 104 to allow blood to flow therethrough.
- a preferred positioning within the left atrium may comprise positioning at least a portion of the bottom surface of the anchoring structure 102 on at least a portion of the upper annular surface of the left atrium as in Fig. 1A.
- the prosthetic leaflet 106 may be positioned above, or spaced away from, the native valve leaflets so that physical interference does not occur between the prosthetic valve leaflet 106 and the native leaflets and to maintain the remaining functionality of the native leaflets.
- device 100 will function to supplement the native leaflet functionality and, if and when needed, will begin to take over progressively more functionality as the native leaflets deteriorate. Eventually, the device 100 will function to replace all, or virtually all of the native leaflet functionality. The result is a device 100 that adapts to progressively assume the functionality of the native leaflets as they deteriorate, from supplementation through full replacement.
- the valve leaflet 106 may be elevated or spaced above the native annular surface so that at least a portion of the valve leaflet 106 in the opened position is also elevated or spaced above at least the upper annular surface. In other cases at least a portion of the valve leaflet 106 in the open position may be disposed above the native valve leaflets so as to not physically interfere with them, or minimize physical interaction therewith. In these embodiments, the prosthetic leaflet may serve at least a supplementary function to the native leaflet function.
- a support for the prosthetic leaflet may be disposed within the native annulus or annular throat, effectively pinning the native leaflets and requiring the inventive valve leaflet to completely replace the native leaflet function.
- the prosthetic leaflet will open in response to increased fluid pressure in the left atrium and allow blood to flow down to the spaced away native leaflets which also open, enabling blood flow to the left ventricle.
- the native leaflets will then close to the extent possible in response to increased fluid pressure in the left ventricle and, in response to the regurgitation pressure in the space between the native leaflets and the prosthetic leaflet, the prosthetic leaflet will then close, preventing retrograde blood flow into the left atrium.
- the prosthetic leaflet will completely handle and manage the blood flow between the left atrium and ventricle.
- prosthetic leaflet 106 opening and leaflet attachment zone 1 10 it is part of the present invention to orient the prosthetic leaflet 106 opening and leaflet attachment zone 1 10 to optimize the supplemental and/or replacement function, for example and without limitation in the case where a single native leaflet is dysfunctional and a result is an eccentric, non-central regurgitation jet.
- the new valve leaflet 106 may be oriented, e.g., so that the eccentric regurgitation jet is focused at the bottom surface of a distal end (away from the leaflet attachment zone 1 10) of the valve leaflet 106, in the middle of the valve leaflet (as measured relative to the distal end and the leaflet attachment zone 1 10), or closer to the leaflet attachment zone 1 10, or at points between the distal end and midpoint, or between the midpoint and the leaflet attachment zone 1 10 in order to maximize closure efficiency of the prosthetic leaflet 106.
- exit flow direction and/or position may be affected by the
- a fully opened prosthetic valve leaflet 106 may comprise opening to a position that is approximately 90 degrees from its closed position. Opening positions for the prosthetic valve leaflet 106 of less than 90 degrees from the closed position will channel the blood flow in a direction along the length of the opened leaflet 106 toward a target on the native leaflets. Thus, as seen in Figure 1A, leaflet 106 may be fully opened to approximately a 45 degree angle relative to its closed position against lower edge 104 of the anchoring structure 102.
- This configuration will direct the incoming blood flow 103 generally along the same direction as the open position of the leaflet 106. Therefore, not only is the opening angle of the leaflet 106 important, but so is the orientation of the anchoring structure 102 on expansion which will dictate the location of the leaflet attachment zone 1 10 which, in turn, dictates the location of the opening leaflet 106 and resultant blood flow therealong.
- Another variable relative to locating the blood flow along the opened leaflet 106 is the distance of the distal end of the opened leaflet 106 from the target region in the native leaflets.
- Figure 3 illustrates an alternate embodiment for a prosthetic valve device 200 that is similar to the prosthetic valve device 100 discussed above in certain respects.
- the anchoring structure 202 has the same or similar features and characteristics as the anchoring structure 102 of device 100, e.g., a collapsible and expandable structure that may comprise a stent-like structure with open cells.
- the valve support structure 204 as illustrated in Fig. 3 comprises two basic elements arranged on opposing sides of a lower opening 201 defined by the anchoring structure 202.
- a first fixed base side 212 that may be more stiff than, or of similar stiffness to, the structure comprising the dome and extends a distance D away from the lower opening 201 and may comprise an expanded and collapsed configurations.
- a moveable, rotatable valve member 214 Positioned across the lower opening 201 from the first fixed base side 212 of valve support 204 is a moveable, rotatable valve member 214 that is connected to, or operatively engaged with, or attached to, or integrally formed with, a second fixed base side 216 that may be of similar stiffness, or different stiffness, as the first fixed base side 212 and may also comprise expanded and collapsed configurations.
- the rotatable valve member 214 may be formed of a tissue or fabric that is less stiff than the second fixed base side 216 and may comprise sizes and shapes as describe above regarding the prosthetic valve of Fig. 1A.
- Fluid flow force generated by blood flow from the left atrium will be sufficient to push the rotatable valve member 214 to an open position as shown in Fig. 4, thereby enabling fluid communication of the atrial blood with the left ventricle.
- those forces cause the valve member 214 to rotate up and close against the first fixed base side 212, preventing regurgitant blood from flowing into the interior of the anchoring structure 202.
- the rotatable valve member 214 may be biased in the closed position, pressed with a predetermined amount of biasing force against the first fixed base side 212, so that the closed position for valve member 214 is the biased position. This requires that the blood flow from the atrium exert sufficient force to overcome the biasing force of the valve member 214 against first fixed base side 212 to cause the valve member 214 to rotate into an open position.
- the valve member 214 may, when closed and as shown, overlap with the inner edge of the first fixed base side 212, so that the upper (upstream) side U of valve member 214 engages the inner edge I of the first fixed base side 212 in the closed position.
- the distal end 220 of valve member 214 may fit against the distal end 220 of the first base fixed side 212 to provide a generally sealed closure.
- the device of Figure 3 may be positioned within the left atrium so that the first and second sides of the base 212, 216 rest upon the upper annular surface with the prosthetic rotatable leaflet 214 positioned over the annulus as in Figure 4 so that the distal end 220 of leaflet 214 may extend into the annulus when in an open position.
- the distance D of extension of the first and second sides of the base 212, 216 may be used to locate and/or position the device 200 slightly within the annulus, with the first and second sides 212, 216 of the base extending downward (downstream) into the annulus as in Figure 5.
- the location of blood flow through device 200 and across rotatable leaflet 214 may be optimized as a system by configuring the degree of angle of maximum opening for leaflet 214, the rotational location of the leaflet 214, specifically the end of the leaflet located away from the point of flexion 218, and the distance or spacing of the end of the leaflet located furthermost from the point of flexion 218 when opened in the open position, i.e., maximum degree of opening.
- system elements that may be optimized for locating the blood flow onto native leaflets comprise the distance of extension of the first base side 212 over the annulus.
- the first base side 212 may not extend over the annulus, instead the distal end 222 of the first base side 212 may be coextensive with an edge of the annulus, see e.g., Fig. 4. In other cases, the distal end 222 of the first base side 212 may extend a distance beyond the annular edge and, therefore, over the annulus the same distance.
- a modified embodiment of the device 200 of Fig. 3 may locate the prosthetic rotatable leaflet 214 at a position that is located above the native annular surface, i.e., in a super annular position, that does not result in any physical touching of the native valve leaflets.
- device 300 comprises an anchoring support 302 and a valve support 330.
- the valve support comprises an inflow end 332 and an outflow end 334 and defines a flow channel therebetween.
- a first base side 336 may be attached along the flow channel of the valve support 330 and a prosthetic leaflet 338 attached at a position along the flow channel of the valve support 330 that enables engagement of the first base side 336 by the prosthetic leaflet 338 when in a closed position.
- the prosthetic leaflet 338 and first base side 336 may be positioned and spaced above the upper annular surface at exemplary position A, though it is understood that the prosthetic leaflet 338 and first base side 336 may be positioned at any point along the flow channel of the valve support 330.
- the prosthetic leaflet 338 and first base side 336 may be positioned at any point between the inflow and outflow ends 332, 334 of the valve support 330 including, but not limited to, a location that is coplanar with the upper annular surface.
- first base side 336 may comprise a very small lip structure to stop the upward rotation of the valve 338 and achieve the closed position to prevent regurgitation.
- the lip structure may surround valve support 338 to form a temporary seal between lip structure / first base side 336 and the closed prosthetic leaflet 338.
- Valve support 330 may be a cylindrical structure as illustrated or may comprise a section of a cone, with increasing distance between the cone sides moving from the inflow end to the outflow end of the valve support 330.
- the valve support 330 may comprise a conical section with decreasing distance between the cone sides moving from the inflow end 332 to the outflow end 334 of the valve support 330.
- Other configurations for the valve support 330 may present themselves to the skilled artisan, each being within the scope of the present invention.
- valve support 330, prosthetic leaflet 338 and fixed first side 336 may be positioned as extended downstream into the native annulus as indicated by position B.
- the valve support 330 terminates at a point above the native leaflets, while in other cases the valve support 330 may extend to and perhaps beyond the native leaflets within the annulus, thereby pinning the native leaflets against the annulus.
- the location of the prosthetic leaflet 338 and fixed first side 336 may be positioned at any point within the valve support 330 between the inflow end 332 and the outflow end 334.
- Valve support 330 in Figs. 6 and 7 may comprise a separate structure that is mechanically connected with the lower opening of the anchoring structure 302.
- the anchoring structure 302 comprises an expandable and collapsible transition section 340 whereby the anchoring structure turns radially inwardly to form the valve support 330.
- the valve support 330, transition section 340, and anchoring structure 302 comprise a unitary structure that may comprise different characteristics in each of the valve support 330, transition section 340 and anchoring structure 302.
- stent cell sizes and/or arrangements may differ between the afore-mentioned device elements 330, 340 and/or 302.
- the unitary construction allows the device of Fig. 6, in some cases, to be turned inside out, by pulling the valve support 330 outwardly and radially away from the anchoring structure.
- a turned-out device when expanded would resemble that shown in Fig. 7.
- This capability is highly advantageous during transition of the collapsed device through a delivery catheter to the heart chamber as the collapsed turned-out device of, e.g., Fig. 7, comprises only two layers as opposed to the non-turned-out device of Fig. 6 which, in the region of the valve support 330 comprises four layers and is, therefore, two layers thicker.
- the device of Fig. 7 is desired in the expanded configuration to position the valve support 330 within the annulus.
- the device of Fig. 6 is desired for positioning the valve support 330 radially within the anchoring support 302 and for allowing location of the prosthetic valve 338 at, or above, the annular surface.
- the device 300 will be reconfigured after release from the distal end of the delivery catheter by pulling the valve support 330 radially back into the anchoring support 302 interior space to achieve the structure of the exemplary device of Fig. 6.
- the embodiment of Figure 6 comprises the inflow end 332 of the valve support 330 is located at a position that is radially within the interior of anchoring structure 302 and the transition section 340 forms the outflow end 334 of the valve support 302, wherein the inflow end 332 of valve support 330 is spaced radially inward and away from the transition section 340.
- the inflow end 332 of the valve support 330 is defined by and substantially coextensive with the transition section 340, with the outflow end 334 of the valve support 330 extending radially outwardly away from the transition section 340.
- Valve support section 404 comprises a first valve flap 406 and a second valve flap 408 that open and close against a lower opening 410 defined by anchoring section 402 and adapted to hingedly engage first and second valve flaps 406, 408.
- Each of the first and second valve flaps 406, 408 may comprise a relatively stiff or rigid outer frame 412 in the general shape of a half circle, or other curvilinear form, and comprise a material on the inner portion 414 of the outer frame, e.g., tissue or fabric or other material with a central straight or linear section 41 1 connecting the two ends of the half-circle-shaped outer frame 412.
- At least one flexion, or hinging, region 416 is provided to bias the first and second valve flaps 406, 408 in the closed position (as shown) and to allow opening of the first and second valve flaps 406, 408 when the biasing force is overcome by blood flow pressure force as described above.
- first and second valve flaps 406, 408 may comprise a sealing engagement together at the central straight or linear section 411 of the outer frame 412. This may be a total or partial seal and may be supplemented by a biocompatible and flexible gasket or liner 420 on one or both of the central straight or linear section 41 1 of the outer frame 412 to ensure sealing when the flaps close together.
- An alternate embodiment shown in Fig. 10 may comprise the first and second valve flaps 406, 408 comprising a sail feature 422 attached at one end to the first and second valve flaps 406, 408 and free to move at the opposing end and comprising material having a generally
- downwardly curving profile when engaged by blood flow from below, may catch upwardly flowing fluid, similar to the way sails catching wind, to flex and aid in generating upward force to close the flaps 406, 408 more efficiently and quickly to prevent regurgitation.
- any prosthetic valve devices described herein including for example the anchoring portions as described herein, as well as the prosthetic valve leaflets or prosthetic valve flaps and/or valve support structures as described herein may comprise a releasable amount of a therapeutic agent thereon for localized application to the heart chamber tissue and/or to the native valves, annulus or other structure.
- the therapeutic agent disposed in or on the prosthetic device may target blood vessels, bodily conduits, or specific organs contacted by the circulatory system to treat, and/or prevent, a bodily disorder and/or accelerate a desired bodily response, e.g., and without limitation endotheliazation.
- Body disorder refers to any condition that adversely affects the function of the body.
- treatment includes prevention, reduction, delay, stabilization, and/or elimination of a bodily disorder, e.g., a failing cardiac valve or a vascular disorder.
- a bodily disorder e.g., a failing cardiac valve or a vascular disorder.
- treatment comprises repairing damage cause by the bodily, e.g., valvular or vascular, disorder and/or intervention of same, including but not limited to mechanical intervention.
- a “therapeutic agent” comprises any substance capable of exerting an effect including, but not limited to therapeutic, prophylactic or diagnostic.
- therapeutic agents may comprise anti-inflammatories, anti-infectives, analgesics, anti-proliferatives, and the like including but not limited to antirestenosis drugs and therapeutic agents that accelerate endothelial coverage and endotheliazation, including but certainly not limited to a therapy stent marketed by
- OrbusNeichTM that is designed to repair vessel injury and regenerate the endothelium, to foster vessel healing achieved by accelerating endothelial coverage and controlling neo-intimal proliferation with a combination of endothelial progenitor cell capture and a sirolimus drug elution.
- Therapeutic agent as used and defined herein further comprises mammalian stem cells.
- Therapeutic agent as used herein further includes other drugs, genetic materials and biological materials.
- the genetic materials mean DNA or RNA, including, without limitation, of
- Viral vectors include adenoviruses, gutted adenoviruses, adeno- associated virus, retroviruses, alpha virus, lentiviruses, herpes simplex virus, ex vivo modified cells (e.g., stem cells, fibroblasts, myoblasts, satellite cells, pericytes, cardiomyocytes, skeletal myocytes, macrophage), replication competent viruses, and hybrid vectors.
- adenoviruses include adenoviruses, gutted adenoviruses, adeno- associated virus, retroviruses, alpha virus, lentiviruses, herpes simplex virus, ex vivo modified cells (e.g., stem cells, fibroblasts, myoblasts, satellite cells, pericytes, cardiomyocytes, skeletal myocytes, macrophage), replication competent viruses, and hybrid vectors.
- Non-viral vectors include artificial chromosomes and mini-chromosomes, plasmid DNA vectors, cationic polymers, graft copolymers, neutral polymers PVP, SP1017, lipids or lipoplexes, nanoparticles and microparticles with and without targeting sequences such as the protein transduction domain (PTD).
- the biological materials include cells, yeasts, bacteria, proteins, peptides, cytokines and hormones.
- peptides and proteins examples include growth factors (FGF, FGF-1, FGF-2, VEGF, Endotherial Mitogenic Growth Factors, and epidermal growth factors, transforming growth factor .alpha, and .beta., platelet derived endothelial growth factor, platelet derived growth factor, tumor necrosis factor .alpha., hepatocyte growth factor and insulin like growth factor), transcription factors, proteinkinases, CD inhibitors, thymidine kinase, and bone morphogenic proteins.
- FGF growth factor
- FGF-1 FGF-1
- FGF-2 VEGF
- Endotherial Mitogenic Growth Factors Endotherial Mitogenic Growth Factors
- epidermal growth factors examples include transforming growth factor .alpha, and .beta., platelet derived endothelial growth factor, platelet derived growth factor, tumor necrosis factor .alpha., hepatocyte growth factor and insulin like growth factor
- transcription factors proteinkinases
- Therapeutic agents further include cells that may be of human origin (autologous or allogeneic) or from an animal source (xenogeneic), genetically engineered, if desired, to deliver proteins of interest at the transplant site.
- Cells within the definition of therapeutic agents herein further include whole bone marrow, bone marrow derived mono-nuclear cells, progenitor cells (e.g., endothelial progentitor cells) stem cells (e.g., mesenchymal, hematopoietic, neuronal), pluripotent stem cells, fibroblasts, macrophage, and satellite cells.
- Therapeutic agent also includes non-genetic substances, such as: anti-thrombogenic agents such as heparin, heparin derivatives, and urokinase; anti-proliferative agents such as enoxaprin, angiopeptin, or monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, amlodipine and doxazosin; anti-inflammatory agents such as glucocorticoids, betamethasone, dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine; antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, methotrexate, azathioprine, adriamycin and mutamycin; end
- the biologically active material can be used with (a) biologically non-active material(s) including a solvent, a carrier or an excipient, such as sucrose acetate isobutyrate, ethanol, n-methyl pymolidone, dimethyl sulfoxide, benzyl benxoate and benzyl acetate.
- a biologically non-active material(s) including a solvent, a carrier or an excipient, such as sucrose acetate isobutyrate, ethanol, n-methyl pymolidone, dimethyl sulfoxide, benzyl benxoate and benzyl acetate.
- therapeutic agent includes, in particular in a preferred therapeutic method of the present invention comprising the administration of at least one therapeutic agent to a procedurally traumatized, e.g., by an angioplasty or atherectomy procedure, mammalian vessel to inhibit restenosis.
- the therapeutic agent is a cytoskeletal inhibitor or a smooth muscle inhibitor, including, for example, taxol and functional analogs, equivalents or derivatives thereof such as taxotere, paclitaxel, abraxane.TM., coroxane.TM. or a cytochalasin, such as cytochalasin B, cytochalasin C, cytochalasin A, cytochalasin D, or analogs or derivatives thereof.
- Additional specific examples of "therapeutic agents” that may be applied to a bodily lumen using various embodiments of the present invention comprise, without limitation: L- Arginine; Adipose Cells; Genetically altered cells, e.g., seeding of autologous endothelial cells transfected with the beta-galactosidase gene upon an injured arterial surface; Erythromycin; Penicillin: Heparin; Aspirin; Hydrocortisone; Dexamethasone; Forskolin; GP Ilb-IIIa inhibitors; Cyclohexane; Rho Kinsase Inhibitors; Rapamycin; Histamine; Nitroglycerin; Vitamin E;
- Vitamin C Stem Cells; Growth Hormones; Hirudin; Hirulog; Argatroban; Vapirprost;
- Thrombin Thrombin
- Thrombin inhibitor Thrombin inhibitor
- Glucosamine Glucosamine
- the therapeutic agent delivery system of the present invention i.e., the prosthetic valve device, may be used to apply the therapeutic agent to any surface of cardiac chambers, e.g., the left atrium, as well as cardiac chambers in fluid or operative communication with the left atrium, e.g., the left ventricle and/or annulus located therebetween.
- the delivery system may be used to deliver an effective amount of therapeutic agent(s) to a body lumen in fluid and/or operative communication with the left atrium and related circulatory system.
- body lumens include, inter alia, blood vessels, urinary tract, coronary vasculature, esophagus, trachea, colon, and biliary tract.
- the therapeutic agent(s) may be coated to some, or all, of the prosthetic valve device as in known in the art to enable a time-release of the therapeutic agent(s) to the target(s) within the patient's body and may be provided so as to enable administration and delivery of an effective dose of the therapeutic agent(s) to the target(s).
- Delivery of the agent(s) may be achieved through pressured contact of the therapeutic agent(s) on or in the prosthetic valve device as it expands against the cardiac chamber when positioned, similar to a coated expandable intravascular balloon or stent.
- the therapeutic agent(s) will then diffuse into the tissue.
- the therapeutic agent(s) may be swept into the blood flow with delivery to other non-cardiac chamber targets, e.g., tissues, organs, lumens, etc., including but not limited to the dysfunctioning native valve structure including leaflets.
- non-cardiac chamber targets e.g., tissues, organs, lumens, etc., including but not limited to the dysfunctioning native valve structure including leaflets.
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2019548635A JP2020509835A (en) | 2017-03-07 | 2018-03-07 | System, method and apparatus for a prosthetic heart valve with a single leaflet |
EP18764951.2A EP3592296A4 (en) | 2017-03-07 | 2018-03-07 | Systems, methods and devices for prosthetic heart valve with single valve leaflet |
CA3054814A CA3054814C (en) | 2017-03-07 | 2018-03-07 | Systems, methods and devices for prosthetic heart valve with single valve leaflet |
CN201880024605.0A CN110505854B (en) | 2017-03-07 | 2018-03-07 | Systems, methods, and devices for prosthetic heart valves having a single valve leaflet |
AU2018231187A AU2018231187B2 (en) | 2017-03-07 | 2018-03-07 | Systems, methods and devices for prosthetic heart valve with single valve leaflet |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US201762468112P | 2017-03-07 | 2017-03-07 | |
US62/468,112 | 2017-03-07 | ||
US15/913,509 US20180256329A1 (en) | 2017-03-07 | 2018-03-06 | Systems, methods and devices for prosthetic heart valve with single valve leaflet |
US15/913,509 | 2018-03-06 |
Publications (1)
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WO2018165225A1 true WO2018165225A1 (en) | 2018-09-13 |
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PCT/US2018/021244 WO2018165225A1 (en) | 2017-03-07 | 2018-03-07 | Systems, methods and devices for prosthetic heart valve with single valve leaflet |
Country Status (7)
Country | Link |
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US (1) | US20180256329A1 (en) |
EP (1) | EP3592296A4 (en) |
JP (1) | JP2020509835A (en) |
CN (1) | CN110505854B (en) |
AU (1) | AU2018231187B2 (en) |
CA (1) | CA3054814C (en) |
WO (1) | WO2018165225A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
US20180256329A1 (en) | 2018-09-13 |
AU2018231187A1 (en) | 2019-10-24 |
JP2020509835A (en) | 2020-04-02 |
AU2018231187B2 (en) | 2020-07-09 |
CA3054814A1 (en) | 2018-09-13 |
CA3054814C (en) | 2022-07-12 |
EP3592296A1 (en) | 2020-01-15 |
CN110505854B (en) | 2022-03-29 |
CN110505854A (en) | 2019-11-26 |
EP3592296A4 (en) | 2020-12-02 |
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